Medical device manufacturer, Gambro, has issued a field safety notice (FSN) concerning its Ultrafilter U9000.
There is a possibility of external fluid leakage with Ultrafilter U9000 as a result of multiple disinfections using a sodium carbonate-based solution. The housing of the Ultrafilter U9000 is made of polycarbonate, a material that is known to undergo slow chemical degradation during long term exposure to alkaline substances. Intensive use of sodium carbonate-based disinfection programs over several months may, therefore, cause degradation of the ultrafilter housing leading to an external fluid leakage at the position of the welding seal between the filter housing and the header cap.
If a leakage is observed during treatment, the user should immediately stop the treatment and change the U9000 Ultrafilter to avoid excessive fluid removal from the patient. Furthermore, the use of sodium carbonate-based disinfection programmes has been broadly validated for the U9000 Ultrafilter. However, to minimize the risk of an external fluid leak, the manufacturer strongly recommends adhering to the instructions mentioned in the FSN, when using sodium carbonate based disinfection programmes with U9000.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 5 Aug 2014